Summary of medicine characteristics - ANHYDROL FORTE 20% W/V CUTANEOUS SOLUTION
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTAnhydrol Forte 20% w/v Cutaneous Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONAluminium Chloride Hexahydrate EP 20.0% w/v.
3 PHARMACEUTICAL FORM
3 PHARMACEUTICAL FORMCutaneous Solution,
Clear, colourless, evaporative cutaneous solution.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the topical treatment of hyperhidrosis specifically involving axillac, hands or feet.
4.2. Posology and Method of Administration
For adults, children and the elderly.
Apply to the affected sites at night; as required, and allow to dry. Wash off in the morning.
4.3. Contra-Indications
Not to be used in cases of sensitivity to any of the ingredients.
4.4. Special Warnings and Special Precautions for Use
Care should be taken to restrict the application to the affected sites only.
Keep away from the eyes.
Care should be taken to avoid Anhydrol Forte coming into direct contact with clothing, polished surfaces, jewellery or metal.
Replace cap tightly after use.
4.5. Interaction with other Medicinal Products and other Forms of Interactions
Do not bathe immediately before use and, if the axillae are treated, do not shave or use depilatories on this area within 12 hours before or after use.
4.6 Pregnancy and Lactation
No special precautions.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
If applied too frequently, Anhydrol Forte may cause irritation which should be treated with a mild topical hydrocortisone cream.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9. Overdose
See section 4.8 above (undesirable effects).
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Aluminium chloride is believed to denature the protein content of sweat issuing from eccrine glands, and to combine with the intraductal keratin fibrils, producing a functional closure. The antibacterial action of the aluminium ion also precludes the development of miliaria. Accordingly, there is no secondary inflammation. The intraluminal pressure rises to the point where it acts as a feedback system, shutting off acinar secretion.
The formulation of Anhydrol Forte has been tested in widespread clinical practice, and has been shown to be effective when used in accordance with the recommended instructions.
5.2. Pharmacokinetic Properties
As the active ingredient is applied in an alcoholic solution of low surface tension, it therefore penetrates into the terminal pores of the sweat ducts, when applied, as recommended, to dry skin. The alcohol then evaporates off leaving the salt deposited in close contact with the lining of the duct. The use of the preparation is restricted to small areas of skin, namely the axillae, hands or feet, to ensure that there are no detrimental effects from widespread obstruction of sweating.
5.3. Pre-clinical Safety data
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Industrial Methylated Spirit BP
6.2. Incompatibilities
None known.
6.3. Shelf-Life
36 months in unopened container
6.4. Special Precautions for Storage
Highly flammable.
Store at room temperature, not exceeding 250C.
Store upright and away from flames.
6.5. Nature and Contents of Container
(According to CPMP List of Allowed Terms (III/3593/91).
10ml glass BOTTLE with roll on APPLICATOR and SCREWCAP.
56ml glass BOTTLE with roll on APPLICATOR and SCREWCAP.
60ml glass BOTTLE with roll on APPLICATOR and SCREWCAP.
60ml HDPE BOTTLE with roll on APPLICATOR and SCREWCAP. These are supplied as original packs (OP).
6.6 Instructions for Use/Handling
Not applicable.
7. MARKETING AUTHORIZATION HOLDER
Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place, Gosmore
Hitchin,
Herts,
SG4 7QR, UK.
8. MARKETING AUTHORIZATION NUMBER
PL 00173/0030
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION11 September 1979 / 8 February 1995.